Archive

One of the common arguments the anti-vaccine advocates use is the “toxins in vaccines” argument. They say that because some substance in vaccines is known to be toxic, such as aluminum, then its mere presence makes vaccines dangerous. What they fail to mention in almost every case however is how much of said substance is in vaccines, and at what levels is this substance toxic.

Water can be toxic to a human in high enough quantities; it’s called drowning. Oxygen can be poisonous; it’s called oxygen poisoning. The list of examples goes on and on but the take home point is this: any substance can be toxic in the right dose; and most substances will not be toxic at low enough levels. As they say the dose makes the poison. The same applies to aluminum.

So, how much aluminum is there in vaccines anyway, and is that level dangerous for babies? To answer that, the Vaccine Education Center at the Children’s Hospital of Philadelphia has set up a short, concise, informative PDF that is available to all, for free, titled “Aluminum in Vaccines: What you should know“. And unlike those in the anti-vaccine camp, the Vaccine Education Center provides all their sources in the PDF itself, for anyone who wants to verify the accuracy of their report.

What they report should satisfy everyone’s curiosity.

During the first 6 months of life, infants could receive about 4 milligrams of aluminum from vaccines. That’s not very much: a milligram is one-thousandth of a gram and a gram is the weight of one-fifth of a teaspoon of water. During the same period, babies will also receive about 10 milligrams of aluminum in breast milk, about 40 milligrams in infant formula, or about 120 milligrams in soy-based formula.

So to put this in perspective: a baby will get 2.5 times the amount of aluminum from breast milk, 10 times the aluminum from infant formula, and 30 times the aluminum from soy-based formula. I know of no babies that are raised without either breast milk or formula, including the babies of each person in the anti-vaccine camp, and any baby who wasn’t vaccinated due to parent’s fear of aluminum toxicity in vaccines.

It appears to me that the anti-vaccine crowd should switch its focus from “greening” vaccines to “greening” baby formula. I hear Big Formula makes a lot of money too out of its product….!

Today we will look at the recent recommendation by the CDC, the American College of Obstetricians and Gynecologists, that, all people over 6 months of age, including pregnant women receive the flu vaccine. Anti-vaccination groups have already come out, insinuating that the safety of the flu vaccine given during a woman’s pregnancy has not been established. Is that true? Are there any studies that have looked at the safety of the influenza vaccine for pregnant women? The answer is yes, at the very least there is one that I was able to find, using simply Google.

Study Summary – The objective of the study was to “evaluate the safety of influenza vaccine that is administered in the second or third trimester of gestation”. A retrospective electronic database search of 5 influenza seasons (July 1, 1998, to June 30, 2003) was performed at a large multispecialty clinic in Houston, Texas. Immunization rates were calculated, and outcomes of pregnancy were compared between healthy women who received influenza vaccine, and a control group of healthy unvaccinated women who were matched by age, month of delivery, and type of medical insurance.

Results – Among 7183 eligible mother-infant pairs, only 252 pregnant women (3.5%) received the influenza vaccine. The mean gestational age at the time of influenza vaccination was 26.1 weeks (range, 14-39 weeks). No serious adverse events occurred within 42 days of vaccination, and there was no difference between the groups in the outcomes of pregnancy (including cesarean delivery and premature delivery) and infant medical conditions from birth to 6 months of age.

Conclusion – This study provides good evidence that pregnant women who receive the flu vaccine during the last 2 trimesters of the pregnancy, and their babies at least up to 6 months of age, face no more risks or complications than pregnant women who do not receive the flu shot during the last 2 trimesters of their pregnancy, and their babies up to 6 months of age. It appears the claims of the anti-vaccination crowd are rejected, at least as far as this study is concerned. The authors concluded as such:

Influenza vaccine that was administered in the second or third trimester of gestation was safe in this study population.

Common vaccinations don’t raise risk of rheumatoid arthritis, easing fears that they’re linked to the inflammatory disease, according to a new study.

Case reports have suggested vaccines, possibly because of their immune-activating adjuvants, could trigger rheumatoid arthritis, a painful autoimmune disease caused by the body’s natural defenses attacking and inflaming joints.

But a study published online Tuesday in the Annals of the Rheumatic Diseases found no link between common vaccinations for flu, hepatitis, diphtheria and other illnesses and an increased risk for rheumatoid arthritis. The study also found no increased risk for patients getting vaccinations who had a genetic susceptibility to the disease, or who were smokers. Smoking has long been thought to be a major risk factor for the disease.

Receiving multiple vaccines also didn’t up the chances of getting afflicted by the joint disease.

“Our results indicate that immunological provocation of adults with common vaccines in their present form is not a major risk factor for RA,” write the authors, led by Camilla Bengtsson, a researcher at the Karolinska Institute in Stockholm, Sweden. “In addition, our results indicate that active immunization does not increase the risk of RA in individuals with established risk factors.”

The MMRV vaccine is a combination vaccine, which combines the MMR vaccine and the Varicella vaccine in a single dose. The MMR vaccine itself is a combination vaccine, providing protection from Measles, Mumps and Rubella. A recent study, published in the journal Pediatrics, shows that the risk for febrile seizures, in the 7-10 day period following receipt of the MMRV vaccine, is twice as big as compared to receiving separate MMR & Varicella vaccines in the same day, for children 12-23 months of age.

Study Summary – The researchers used 2000–2008 Vaccine Safety Datalink data to compare seizures and fever visits, restricted to emergency room or hospital visits, among children aged 12 to 23 months, during the 42 days after receipt of the MMRV vaccine, or the separate MMR + varicella vaccines. The study population included 83, 107 children vaccinated with MMRV between January 2006 and October 2008 and 376, 354 vaccinated with MMR varicella between January 2000 and October 2008. The secondary comparison groups consisted of 145, 302 children who received MMR vaccine alone and 107, 744 who received varicella vaccine alone from 2000 to 2008. The authors monitored weekly seizure visits and compared the rates between the vaccines.

Results – After vaccination with all measles-containing vaccines, seizure incidence peaked during days 7 to 10; the most prominent peak was recorded after MMRV vaccination. During days 7 to 10, unadjusted rates for seizures were 84.6 seizures per 1000 person-years after MMRV vaccination, 42.2 seizures per 1000 person-years after MMR + varicella vaccination, and 26.4 seizures per 1000 person-years after MMR vaccination alone. Unadjusted rates during days 7 to 10 were nearly 8 times higher for MMRV and 4 and 3.5 times higher for MMR varicella and MMR vaccination alone, as compared to Varicella vaccine alone.

Conclusion – The study looked at over 459 000 children, 12-to-23 months of age, who were vaccinated with either the MMRV vaccine, or separate MMR & Varicella vaccines, and found the MMRV to be associated with increased fever and seizures 7-10 days following vaccination. When compared to separate MMR + Varicella vaccine received at the same time, the combination MMRV vaccine was associated with a two-fold increase in risk of having a febrile seizure in the 7-10 days following vaccination. The authors estimated this meant 1 additional case of febrile seizure for every 2,300 doses of MMRV vaccine given, as compared to separate MMR & Varicella vaccines received at the same time. There was no difference in seizure risk outside of the 7-10 day window. The study shows that both MMRV, and MMR+Varicella vaccines are associated with increased seizure risk in the 7-10 day window, as compared to Varicella vaccine alone, with the risk from MMRV being twice as high as the separate MMR+Varicella vaccinations. Here is what the authors of the study had to say:

Among 12- to 23-month-olds receiving their ﬁrst dose of measles-containing vaccine, the risk of fever and seizure are elevated 7 to 10 days after vaccination. The use of MMRV vaccine instead of separate MMR varicella vaccines approximately doubles the risk for fever and febrile seizures, resulting in 1 additional febrile seizure for every 2300 doses of MMRV vaccine administered instead of separate MMR and varicella vaccines.

Bottom Line: Talk to your pediatrician about this; it appears the best route is to take the separate MMR+Varicella vaccines as opposed to the single MMRV shot. Febrile seizures are fairly common, with 1 in 25 children experiencing at least one seizure. While witnessing a child going through one is scary, they are generally harmless. According to the National Institute of Neurological Disorders and Stroke:

Although they can be frightening to parents, the vast majority of febrile seizures are harmless. During a seizure, there is a small chance that the child may be injured by falling or may choke from food or saliva in the mouth. Using proper first aid for seizures can help avoid these hazards (see section entitled “What should be done for a child having a febrile seizure?”).

There is no evidence that febrile seizures cause brain damage. Large studies have found that children with febrile seizures have normal school achievement and perform as well on intellectual tests as their siblings who don’t have seizures. Even in the rare instances of very prolonged seizures (more than 1 hour), most children recover completely.

Between 95 and 98 percent of children who have experienced febrile seizures do not go on to develop epilepsy. However, although the absolute risk remains very small, certain children who have febrile seizures face an increased risk of developing epilepsy. These children include those who have febrile seizures that are lengthy, that affect only part of the body, or that recur within 24 hours, and children with cerebral palsy, delayed development, or other neurological abnormalities. Among children who don’t have any of these risk factors, only one in 100 develops epilepsy after a febrile seizure.

Results – No significant differences were seen between TIV and placebo groups for any safety outcome. Fever > or =38 degrees C within 3 days of vaccination was seen in 11.2% versus 11.7% of TIV versus placebo recipients. Serious adverse events within 28 days were reported in 1.9% of TIV and 1.5% of placebo recipients. Antibody responses to childhood vaccines were similar in both groups. Increased influenza-specific antibody responses in TIV recipients compared with placebo recipients were seen against all 3 strains in TIV recipients, with better responses to influenza A strains noted. Reciprocal geometrical mean titer to H1N1, H3N2, and B were 33, 95, and 11 in TIV recipients versus 7, 9, and 5 for placebo recipients.

Conclusion – This study fulfills all the basic requirements for a well designed scientific study. The sample was large (1,375 participants); it was double-blind, randomized and placebo controlled. This study showed that the trivalent, inactivated flu vaccine was just as safe as the placebo and highly more efficient than placebo in inducing antibody response to all three strains of the virus. The authors concluded as such:

TIV administered to young infants beginning at 6 to 12 weeks of age is safe and immunogenic.

Guillain-Barre Syndrome is a rare neurological disorder (affecting about 1.65 and 1.79 in 100,000) in which the body’s immune system attacks part of the peripheral nervous system. On some occasions, it has been identified to be triggered by surgery or vaccination. For example, as has been widely reported, especially by the anti-vaccination crowd, the 1976 influenza A (H1N1) vaccine was associated with a statistically significant increased risk for GBS of over 10 cases per million, and it appears that some vaccines may account for a slight overall increase in GBS risk.

Given the history with the 1976 H1N1 vaccine, the CDC has been closely monitoring the 2009 H1N1 vaccines, through its Emerging Infections Program (EIP) since October 2009. Preliminary results of this analysis show an excess of 0.8 cases of GBS for 1,000,000 vaccinations, similar to the rate for seasonal influenza vaccines. If this holds up when the full review is released some time in the Fall of 2010, it would mean that the 2009 H1N1 vaccine will be associated with an 8% increase over the expected GBS rate of 1 in 100,000.

To put things in perspective, while the H1N1 vaccine may be associated with less than 1 additional case of GBS per million vaccines, the disease it protects from, H1N1 influenza has been associated with 9.7 deaths per million. According to Wikipedia, 80% of GBS patients recover fully, which means that of the 0.8 additional cases per million vaccination, only about 0.16 will have permanent effects (including paralysis and death). To put this further into perspective, if this association holds, we should expect about 16 cases of additional GBS with permanent side effects, for every 100,000,000 vaccinations. At the same time the death rate from influenza A (H1N1) would be at about 970. And if that is not enough perspective, according to this study, the mortality rate, at least for the period 2000-2004 was at 2.58 %, whereas Wikipedia estimates overall mortality rate to be at around 4%. Using the larger number, the 4% from Wikipedia, if the association holds at the same level, we would expect an additional 3.2 vaccine induced GBS deaths versus 970 influenza H1N1 deaths, per 100 million people.

Even if the H1N1 vaccine is only 50% effective in preventing H1N1 influenza, that’s still 485 saved lives vs. 3.2 additional deaths. This overwhelmingly shows that vaccinating for influenza A (H1N1) is to be highly preferred vs. not vaccinating, since the chances of any one person dying from influenza would be about 151 times higher than dying from vaccine induced GBS. To put it differently, every person that chooses not to vaccinate for H1N1 out of fear of dying of vaccine induced GBS, is effectively choosing to take a risk of dying from the disease 151 times higher than the one they are afraid of (and this is only at an assumed 50% vaccine efficacy rate)! That is kind of like preferring to jump out of the 10th floor of a building because you’re afraid you may break your leg jumping out of the first floor window.

The question of safety is the main vaccine concern. Are vaccines safe? If I vaccinate my child, will that have negative effects for their health? Of course, these questions are extremely broad to be answered all at once. Thus I will be breaking the answers in little bits. Today we will look at the MMR (Measles, Mumps & Rubella) vaccine and autism. Is the MMR vaccine correlated with autism? A quick PubMed search found this study from the June 12, 1999 Lancet (the same journal that originally published and recently retracted the Wakefield study that is widely credited with starting the MMR/vaccine hysteria):

Department of Community Child Health, Royal Free and University College Medical School, University College London, UK

Study Summary: The authors looked at data about autism diagnoses since 1979 and data about MMR vaccinations, which started in 1988 in the UK, to try to see if there is any increase in autism diagnoses in or around the time when the MMR vaccine was introduced. They found that autism rates were steadily increasing every year and no “step-up” in autism diagnoses occurred when the vaccine was introduced, thus lending credibility to the conclusion that MMR does not seem to increase autism rates.

There was a steady increase in cases by year of birth with no sudden “step-up” or change in the trend line after the introduction of MMR vaccination. There was no difference in age at diagnosis between the cases vaccinated before or after 18 months of age and those never vaccinated. There was no temporal association between onset of autism within 1 or 2 years after vaccination with MMR (relative incidence compared with control period 0.94 [95% CI 0.60-1.47] and 1.09 [0.79-1.52]). Developmental regression was not clustered in the months after vaccination (relative incidence within 2 months and 4 months after MMR vaccination 0.92 [0.38-2.21] and 1.00 [0.52-1.95]). No significant temporal clustering for age at onset of parental concern was seen for cases of core autism or atypical autism with the exception of a single interval within 6 months of MMR vaccination. This appeared to be an artifact related to the difficulty of defining precisely the onset of symptoms in this disorder. INTERPRETATION: Our analyses do not support a causal association between MMR vaccine and autism. If such an association occurs, it is so rare that it could not be identified in this large regional sample.

Now, let us keep in mind that, one study never proves anything. At best one study points to a possible direction, no matter how well done, and how rock solid that one study may appear. What matters is the literature as a whole; what do all the studies done on the topic suggest. As such, given that this is the first study about vaccines & autism we’ve reviewed here, let us not interpret this as proof that the MMR vaccine is not correlated to autism. Only when we have found more studies, and only when all the studies appear to reach the same conclusion can we say with any level of certainty that it appears highly unlikely that the MMR vaccines causes an increase in autism levels.